MDACC Study Summary COGAHOD03P1

Study Summary
No. COGAHOD03P1:.......Lymphoma; Pediatrics......Cesar Nunez......Pediatrics

Study Summary Title



Study Summary Number:	COGAHOD03P1

Study Title:	Treatment of Children with Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD)

Physician

New Patient Referral



Name:	Cesar Nunez	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Pediatrics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6620 Contact us about clinical trials

General Information



Disease Group:	Lymphoma Pediatrics	Supported By:	NCI through COG

Phase of Study:	N/A	Return Visit:	At least once per week during the chemotherapy period and daily (Monday to Friday) during the Radiotherapy period.

Treatment Agents:	Cyclophosphamide Doxorubicin Prednisone Vincristine Sulfate	Home Care:	Prednisone by mouth.

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	New pts may need 3-5 days of hospitalization at the beginning of Induction period. Later, the pt. may require admission for administration of IV chemotherapy for 1-2 days, at day 1 of the cycle, if chemo adminsitration not tolerated as an outpatient.


Description/ Intervention:	The goal of this clinical research study is to see if patients with LPHD can be treated with less chemotherapy and radiation, and still have the same level of response. Researchers want to find out if later side effects of treatment can be lowered or prevented by using less chemotherapy and radiation.

Study Objectives / Outcomes

1) To preserve the excellent cure rate in patients with LPHD while employing a treatment strategy that minimizes the exposure to chemotherapy and radiation therapy in appropriate patients.
2) To estimate the proportion of Stage I patients (with a single involved lymph node that is totally resected) who can be cured with surgery alone.
3) To estimate the proportions of Stage I unresected, Stage I resected (whose disease has recurred after observation), and Stage II LPHD patients who can be cured with AV-PC x 3, with IFRT for those who are not in a CR after chemotherapy.
4) To reduce the potential for long- term toxicity of LPHD treatment.

Study Status Information



Study Activation / Registration Date:	12/04/2006

IRB Review and Approval Date:	12/04/2006

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	150

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Ages 0 - 21 years inclusive.

2) Patients with newly-diagnosed, previously untreated, biopsy-proven lymphocyte predominant Hodgkin disease are eligible for this protocol as follows: Diagnosis of LPHD must be made using the R.E.A.L/WHO classification criteria and will be confirmed by rapid pathology central review. Clinical stages as follows: Stage IA without bulk disease Stage IIA without bulk disease.

3) Study enrollment must take place within 5 calendar days of beginning protocol therapy.

4) Slides for rapid central pathology review must be sent to the BPC.

5) The diagnostic specimen (diagnostic pathology slides) must be sent for rapid review by the time of study enrollment.

6) Adequate renal function: Creatinine clearance or radioisotope GFR >/= 70 ml/min/1.73 m^2; OR, 2) maximum serum creatinine (md/dL) based on age/gender as follows: 1 month to < 6 months: 0.4 md/dL; 6 months to < 1 yr: 0.5 md/dL; 1 to < 2 yrs: 0.6 md/dL; 2 to < 6 yrs: 0.8 md/dL; 6 to < 10 yrs: 1 md/dL; 10 to < 13 yrs: 1.2 md/dL; 13 to < 16 yrs: Male: 1.5 md/dL; Female: 1.4 md/dL; >/= 16 yrs: Male: 1.7 md/dL; Female: 1.4 mg/dL.

7) Adequate liver function defined as : - total bilirubin </= 1.5 x upper limit of normal (ULN) for age, and SGOT (AST) or SGPT (ALT) < 2.5 x upper limit of normal (ULN) for age.

8) For patients that will receive chemotherapy, adequate cardiac function, defined as: - Shortening fraction of >/= 27% by echocardiogram, or - Ejection fraction of >/= 50% by radionuclide angiogram (MUGA).

9) Female patients of childbearing potential must have a negative pregnancy test if they are to receive chemotherapy or radiation treatment. Lactating females must agree that they will not breastfeed a child if they are to receive chemotherapy or radiation treatment. Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method if they are to receive chemotherapy or radiation treatment.

10) Pregnant or breastfeeding women with Stage I, single involved lymph node and confirmed (by QARC) total resection, are eligible for the observation arm only. No chemotherapy or radiation treatment will be administered to pregnant or breastfeeding women.

11) Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method if they are to receive chemotherapy or radiation treatment.

12) All patients and/or their parents or legal guardians must sign a written informed consent.

13) All institutional, FDA, and NCI requirements for human studies must be met.

Exclusion Criteria:

1) Patients > 21 years of age.

2) Patients with "B" symptoms or bulk disease are NOT eligible for this study.

3) Patients may not have received any previous chemotherapy or radiation therapy.

4) Patients may not have received systemic corticosteroids within 30 days of enrollment on this protocol

Links

Registration Number: NCT00107198
Study Information on Clinical Trials Registry (clinicaltrials.gov)